Cerebrolysin hydrolysate injection and preparation method thereof

Abstract

The invention discloses a cerebrolysin hydrolysate injection and a preparation method thereof. The preparation method of the cerebrolysin hydrolysate injection comprises the following steps: (1) preparing a fresh and healthy pig brain, removing adipose tissues, homogenizing, vacuumizing at 8Pa, maintaining the pressure for 10 minutes, introducing CO2 until the pressure is 15Pa, and maintaining the pressure for 20 minutes; (2) slowly adding the defatted brains obtained in the step (1) into liquid CO2 in an amount which is 7 times of that of the defatted brains, stirring for 50 minutes, cooling down to the temperate being from -70 to -80 DEG C, keeping for 3 hours, and then increasing the temperature to 45 DEG C within 8 minutes to gasify CO2; (3) adding water for injection in an amount which is 3 times of that of the frozen-thawed brains obtained in the step (2), uniformly stirring, further adding papain or pepsin of which the weigh is equivalent to 0.7% of the weight of the frozen brains, and carrying out hydrolysis at 37 DEG C for 3.5 hours to obtain an enzymatic hydrolysate; and (4) centrifuging the enzymatic hydrolysate, taking a supernatant liquid, adding 1%-10% of HS-15, carrying out activated carbon adsorption at the room temperature, carrying out decarbonization and filtering, regulating the pH value, and filtering after an intermediate is examined to be qualified, so as to obtain the cerebrolysin hydrolysate injection. By virtue of a brand new prescription and process, the prescription safety of the cerebrolysin hydrolysate injection is obviously improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cerebroprotein hydrolyzate injection and a preparation method thereof. Background technique [0002] Cerebroprotein hydrolyzate injection is an active peptide hydrolyzate extracted from fresh brain tissue of healthy pigs, containing a variety of amino acids, cephalin, lecithin, and peptide nerve growth factors. It is used to improve symptoms such as insomnia, headache, memory loss, dizziness and irritability, and can promote the rehabilitation of sequelae of traumatic brain injury, sequelae of cerebrovascular disease, sequelae of encephalitis, acute cerebral infarction and acute brain trauma. [0003] Since it went on the market in the 1990s, it has been widely used in the treatment of dementia, cerebrovascular disease and ischemic encephalopathy. It is an economical, safe, small adverse reaction and highly effective brain cell rejuvenating agent, but brain ...

AI Technical Summary

Problems solved by technology

[0003] has been widely used in the treatment of dementia, cerebrovascular disease and ischemic encephalopathy since it was launched in the 1990s. It is an economical, safe, small adverse reaction, It is a highly effective brain cell energizing agent, but cerebroprotein hydrolyzate injection can also cause anaphylactic shock. Allergic reactions such as abdominal pain, and anaphylactic shock in severe cases

Now check a number of commercially available cerebroprotein hydrolyzate injections and find that the instructions contain Tween-80. Modern medical literature has confirmed that Tween-80 is the main cause of adverse reactions (anaphylaxis) during clinical use.